Bradley Merrill Thompson Quoted in “Senate Bill Undermines FDA Regulatory Role”


Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Senate Bill Undermines FDA Regulatory Role."

Following is an excerpt:

Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) announced that they introduced a bill--the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014--that targets the FDA's role. Like its companion bill in the House, the PROTECT Act in the Senate tries to paint a picture of the FDA as a maniacal, overreaching regulatory agency that is stifling innovation in the nascent mHealth industry. ?...

"The biggest issue with both the SOFTWARE Act and the PROTECT Act is that it would deregulate certain standalone software used for such things as guiding therapeutic decision-making," Bradley Merrill Thompson, the mHealth Regulatory Coalition's general counsel, told FierceMobileHealthcare. "For example, under both acts, a radiation dosage calculator would be removed from FDA regulation even though there is considerable risk in using such a program." ?...

"Fundamentally the Senate legislation would make NIST responsible for technical standards and take FDA completely out of the equation," said Thompson. "That's just a terrible idea. FDA has a lot of experience in this area. They also have statutory authority that would be useful to regulating certain types of high risk health IT."